The present invention relates to a suction drainage device, particularly a medical suction drainage device adapted to be communicated with a body cavity to drain body fluids therefrom. More particularly, the present invention relates to a medical suction drainage device which can be used as a receptacle for body fluids, e.g. wound secretions and/or excretions, and in which a vacuum can be created by manually conditioning the device.
In the postoperative draining of wounds and the like, it is common practice to insert a catheter, for example a flexible drainage catheter, into the wound, which is closed for example by sutures or surgical clamps, to remove fluids which form as the wound heals. After the wound heals, the catheter is removed by extraction. It has been found to be advantageous to apply a vacuum to such flexible drainage catheters which frequently have multiple perforations over a part of their length. The vacuum not only speeds up the removal of fluids from the wound but also presses the cut edges of the surgical wound together, thereby stimulating rapid tissue granulation and healing of the wound. Systems which include a flexible catheter drainage tube with multiple perforations in the wall of the catheter and a pre-evacuated vacuum reservoir connected to the catheter are known, for example, as Redon drainage systems.
Such drainage systems can be supplied as reusable devices and as single use disposable devices. Single use disposable systems are advantageous for hygienic and economic reasons and, as a vacuum source, utilize, for example, a glass bottle evacuated to a predetermined partial vacuum of 0.1 bar, for example. The vacuum existing in such systems is in many cases qualitatively indicated on a dial. Although reusable systems can be worn by ambulatory patients, they are not entirely satisfactory because of susceptibility to breaking, their weight, the unfavorable geometric shape of the glass bottle, and especially because the wall thickness of the tube required for stability under high vacuum results in a clumsy and relatively rigid drainage system.
Devices intended for a single disposable use, normally made of plastics, are often more favorable in the above respects because they are at least lightweight and unbreakable. Such single use systems can comprise, for example, a flexible plastic container which can be compressed like an accordion and expanded by a spring force. A vacuum chamber is created in the container by compression, for example, and after the drainage catheter has been connected to the container, the necessary suction is created by expansion aids in the container.
While on the one hand it is desirable to have a relatively high vacuum available from the vacuum source to promote healing, a high vacuum is disadvantageous on the other hand because the tissue adjacent to the wound on the outside of the catheter can be sucked and pressed into the holes of the catheter under high vacuum, particularly in the case of brain and breast operations, so that upon the removal, i.e. extraction of the catheter, the wound can be torn open again and new trauma can be created in the original wound. Another disadvantage results from the presence of the collected body fluids in the receptacle as unrestrained liquids since such fluids, which can be infected, can through inadvertence of medical personnel flow back into the catheter. In addition, if a glass bottle is used and breaks, the fluids escaping from the broken bottle can contaminate the environment and medical personnel.
The above defects are largely remedied by the device described in U.S. Pat. No. 3,572,340 (Lloyd et al.) which comprises a collapsible bag receptacle of flexible material filled with a material which absorbs body fluids as the volume of the material expands. In the center of each of two opposite edges of the receptacle bag an opening is formed provided with a connector or nipple. The opening and nipple in one edge form an inlet for body fluids and the opening and nipple in the other edge form an outlet for air. The body fluid inlet nipple has a ball valve associated with it to prevent the return flow of body fluids from the receptacle bag into the patient. A disadvantage in using a ball valve is clogging of the ball valve particularly when the body fluids being sucked out of a wound include a colloid-containing protein solution which agglutinates, especially at the body temperatures at which the bags are being worn where coagulation of the solution readily occurs. Since the bag receptacle can not be rolled up over a large roll length because of the two centrally arranged nipples, the bag receptacle cannot be fully deaerated and the full volume expansion capacity of the filling material is not utilized for the absorption of body fluids. Hence, the bag receptacle must be changed more frequently. When the bag receptacle is made with only the inlet nipple, problems arise with deaeration because the ball valve must be deactivated to allow the air to escape. To alleviate those problems, the ball valve can be lodged in a separate part which is coupled through fittings with the inlet nipple only after evacuation occurs. This additional part unduly increases the cost of the device intended for a single disposable use. Another factor contributing to cost is the design of the valve as a ball valve.